Useful models for biotechnology hazard identification: What is this thing called ‘familiarity’?

The notion of ‘familiarity’ has been propagated as a new policy tool to bridge the gap between scientific expertise and regulatory practice in the context of biotechnology risk assessment. This chapter analyses the scientific merits of the concept of familiarity. This criterion is designed to amalgamate normative and scientific aspects of the biosafety issue. Understanding the scientific meaning of ‘familiarity’ in this context is a prerequisite for appreciating its normative role in regulatory decision-making. The concept of ‘familiarity’ can only serve its purpose in biosafety assessment when it is reconstructed in terms of its underlying biological models. The Economic Cooperation and Development has cited familiarity with the environment as a relevant safety consideration. However, when it comes to identifying possible impacts of genetically manipulated organisms on ecosystems, there is no such thing as ‘familiarity with the environment’ without explicit consideration of the interactive relations between that environment and the organism.